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First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Exploring STX-478 for advanced tumors, alone or with other treatments.

Recruiting
18 years and older
All
Phase 1/2

This study is exploring a new treatment called STX-478 for advanced solid tumors. Solid tumors are lumps of cancer cells, and advanced means they've spread a lot. The study is in two parts. Part 1 tests STX-478 alone, and Part 2 tests it with other cancer medicines, like fulvestrant, which is a hormone therapy. This study is open-label, meaning both doctors and patients know what treatment is being given. It's a Phase 1/2 study, which means it's early in research, focusing on safety and how the body processes the drug.

Participants need to be 18 or older, have a tumor with a specific genetic change (PI3Kα mutation), and be fit enough for treatment. They can't join if they have certain other health issues or have had recent cancer treatments.

  • Duration: Each study part begins with a 28-day screening period, followed by treatment.
  • Visits: Regular visits to the study site will be needed for monitoring.
  • Risks: Potential side effects from STX-478 and other treatments.
Study details
    Breast Cancer
    Solid Tumors
    Adult

NCT05768139

Eli Lilly and Company

14 March 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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